tbuckley/cabot-search huggingface dataset:
Effectiveness of a video-based educational training program to enhance primary care providers confidence and self-efficacy in the management of cancer survivors.
Authors: Katherine Ramsey Gilmore, Linh K. Nguyen, Julie S. Bortolotti, Nancy N. Nguyen-Vu, Hannah Reygaerts, Lance Johnson, Ronda L. Hartman, Thomas J. Murphy, Maria Alma Rodriguez
Journal: Journal of Clinical Oncology (2023)

e24194 Background: As of January 2019, there were over 1.1 million cancer survivors residing in Texas. It is well documented that primary care providers (PCPs) currently care for a large number of cancer survivors but may not receive adequate training to offer comprehensive survivorship care. Through training and education, this project aims to increase the confidence and self-efficacy of PCPs providing care to survivors and to improve overall health outcomes based on comprehensive domains of care. Methods: Focus groups and surveys were conducted with PCPs in a community-based family practice to identify potential knowledge gaps and confidence related to survivorship care. We developed and distributed a video-based training curriculum consisting of four domains of survivorship care and the management of four common cancers. We used the Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) to conduct pre- and post-training evaluation. Results: Seventeen (100%) providers completed the pre- and post-training SPARCCS. The survey results showed that 94% of the PCPs have previously provided care for patients diagnosed with cancers. However, prior to training only 6-18% felt very confident in their knowledge of cancer-related follow-up care for breast, colorectal, lung, and prostate cancer survivors and 24-41% felt not at all confident. All participants completed 8 video-based education modules (approximately 6 hours of education). Post-training results indicated 18-29% of providers felt very confident in the domains in questions and only 12% lacked confidence related to the management of long-term and late physical adverse effects (Table 1). Conclusions: Video-based educational training can improve the confidence and self-efficacy of PCPs in the care and management of cancer survivors. Continued evaluations are planned to assess the sustainability of this demonstrated improvement over time. [Table: see text]
Disparities in rectal cancer initial staging evaluation for distant metastasis.
Authors: Brittany Le, Angelina Lo, Jason A. Zell, Sonia Lee
Journal: Journal of Clinical Oncology (2023)

e18589 Background: About a quarter of rectal cancer patients will present with metastasis. Since metastasis dictates prognosis and treatment, detection is crucial. NCCN guidelines recommend CT of the chest, abdomen and pelvis (CT CAP) over PET/CT. Systemic race/ethnic disparities and poor access to health care have been associated with lower utilization of radiologic imaging. Here, we set out to assess disparity in initial radiology work up for rectal cancer metastasis. Methods: We reviewed consecutive rectal cancer cases at our academic institution from 2015 to 2020. Patients with inadequate history, workup performed in foreign country, or those who may not benefit from completion of imaging evaluation were excluded. Sociodemographic data, payer information and clinical history were collected from EMR. Zip code was used to assess SES and to assess for rural-urban community area (RUCA) code. Descriptive analysis, unadjusted odds ratios, and t-tests were used for analysis. Results: Among the 421 subjects, 339 met inclusion criteria. 133 were female (39.2%) and the mean age of the group was 58.6+/-13.5 years. 214 patients (63.1%) had CT CAP performed. Subjects aged 65+ were 41% less likely to have CT CAP completed compared to patients aged 24-64 (95% CI 0.37, 0.97). Subjects with Medicare coverage are 48% less likely to have CT CAP than those with private insurance coverage (CI 0.29, 0.92). Subjects who live in zip codes with median family income below the 50th percentile were 55% less likely to have CT CAP than those who live in zip codes with higher income (CI 0.27, 0.74). Subjects who live in urbanized areas were 3.87 times more likely to have CT CAP completed than those from non-urbanized areas (CI 1.53, 10.6). Subjects who were diagnosed in 2019-2020 were 1.81 times more likely to have CT CAP imaging completed compared to patients diagnosed before 2017. Race and ethnicity and BMI were also assessed, but no disparities were observed. Conclusions: Young age, private insurance, higher SES, urban neighborhood, and more recent diagnosis are associated with receipt of NCCN recommended radiologic evaluation of metastasis in rectal cancer. [Table: see text]
Circulating tumour DNA (ctDNA) as a predictor of clinical outcome in non-small cell lung cancer undergoing targeted therapies: A systematic review and meta-analysis.
Authors: Farzana Yasmin Zaman, Ashwin Subramaniam, Afsana Afroz, Zarka Samoon, Walid Zwieky, Surein Arulananda, Muhammad Alamgeer
Journal: Journal of Clinical Oncology (2023)

e21124 Background: Liquid biopsy (LB) analysis using circulating-tumour DNA (ctDNA)/cell-free DNA (cfDNA) is an emerging alternative to tissue profiling in non-small cell lung cancer (NSCLC). LB is used to guide treatment decisions, detect resistance mechanisms, and predicts responses, and therefore outcomes. This systematic review and meta-analysis evaluated the impact of LB quantification on clinical outcomes in molecularly altered advanced NSCLC undergoing targeted therapies. Methods: We searched Embase, MEDLINE, PubMed and Cochrane Database, between 01/01/2000 and 01/08/2022. The primary outcome was progression-free survival (PFS) and overall survival (OS). Secondary outcomes included objective response rate (ORR), sensitivity and specificity of the test. Age stratification was performed based on the mean age of the individual study population. The quality of studies was assessed using the Newcastle-Ottawa Scale (NOS). Results: Twenty-seven studies reporting 2424 patients were included. Eleven studies (n = 1359) reported an association of baseline ctDNA levels, while 16 studies (n = 1649) reported an association of dynamic ctDNA changes to treatment, with clinical outcomes of PFS and/or OS. Baseline ctDNA-negative patients had higher PFS (pooled hazard ratio [pHR] = 2.97; (95%CI: 1.92-4.85; I 2 = 97.4%), and OS (pHR = 3.49; (95%CI: 1.73-6.95; I 2 = 84.2%), than ctDNA-positive patients. Egger’s test suggested publication bias (p &lt; 0.001). Early reduction/clearance of ctDNA levels after treatment improved PFS (pHR = 3.78; 95%CI: 1.91-7.38; I 2 = 98.4%) and OS (pHR = 2.20; 95%CI: 1.49-3.28; I 2 = 90.6%), compared to those with no reduction/persistence of ctDNA levels. The PFS was comparable for patients stratified by age (age ≤60 years [pHR = 2.92; 95%CI: 1.43-5.93; I 2 = 98.3 %] vs. age &gt; 60 years [pHR = 3.94; 95%CI: 1.54-10.07; I 2 = 83.6 %]). The sensitivity analysis based on study quality (NOS) demonstrated improved PFS only for good quality studies (pHR = 3.67; 95%CI: 1.79-7.54; I 2 = 91.6 %), but not for poor or fair quality studies. Conclusions: This large systematic review, despite heterogeneity, found that baseline negative ctDNA levels, and early reduction in ctDNA following treatment are strong prognostic markers for PFS and OS in patients undergoing targeted therapies for advanced NSCLC. Future randomised clinical trials should incorporate serial ctDNA monitoring to further establish the clinical utility in advanced NSCLC management. Systematic review registration: PROSPERO registration No. CRD42022347791 Keywords: non-small cell lung cancer; NSCLC; liquid biopsy; circulating tumour DNA; ctDNA; progression-free survival; targeted therapies.
Liquid and tissue profiling of somatic mutational landscape of non-small cell lung cancer from an Indian cohort.
Authors: Sewanti Atul Limaye, Umut Disel, Nick Plowman, Nitesh Rohatgi, Nelofer Syed, Datar Limited, Vineet Datta, Darshana Patil, Nirmal Vivek Raut, Dr T Raja, Razelle Kurzrock
Journal: Journal of Clinical Oncology (2023)

e21202 Background: Circulating tumor DNA (ctDNA) encompasses spatial and temporal heterogeneity, tumor evolution, and is ideal for repeat sampling and predictive therapeutic course corrections whereas tissue is the first choice for molecular profiling. We report the mutational landscape of an Indian NSCLC cohort, with focus on liquid biopsy and value addition offered by paired tissue and liquid profiling. Methods: The study comprised 507 tumor tissue and 1271 liquid biopsies from NSCLC patients. Evaluation of single nucleotide alterations, copy number alterations and fusions was conducted using targeted next generation sequencing with paired tissue and liquid profiling in a sub cohort (n = 45). Results: In tissue based analysis (n = 507), EGFR-sensitizing mutations were the most common alterations, detected in 41.4% of samples. Among these, Exon 19 deletion was seen in 46.3%, Exon 21 L858R in 23.9%, Exon 20 insertion in 4.6%, Exon 18 G719X in 3.7% and compound mutations in 5%. TP53, KRAS and PIK3CA mutations were detected in 34.5%,13.4% and 6.3% respectively. MYC was commonly amplified (15.4%) gene followed by PIK3CA (4.1%), CCNE1 (3.3%), EGFR (2.9%), and MET (2.9%) amplifications. Tissue fusion analysis (n = 398) detected ALK in 6.3%, ROS1 in 3.3%, and RET in 1.8%. METEx14 was detected in 4.5%. Liquid biopsy (n = 1271) showed comparable mutation spectrum as tissue, with the EGFR gene being the most altered (32.9%). Mutations in TP53 were observed in 26.4%, KRAS in 7.4%, PIK3CA in 4.4% and BRAF in 3%. In EGFR positive individuals, EGFR T790M was detected at higher frequency in liquid (16.7%) than tissue (8.6%), indicating this acquired resistance alteration being better captured in liquid biopsy than tissue due to tumor heterogeneity and tumor evolution. 2 liquid biopsy samples identified additional KRAS driver mutations not seen in the paired tissue analysis, highlighting the utility of simultaneous tissue and liquid analysis. Concurrent actionable alterations were detected in 11% of tissue and 5% of liquid samples. Conclusions: We report the largest liquid biopsy study reporting the genomic landscape from NSCLC cases of Indian origin along with tissue based molecular landscape. Presence of alterations like KRAS and EGFR T790M in liquid but absence in concurrent tissue biopsy shows utility of paired tissue and liquid biopsy profiling. Higher incidence of targetable and co-existing alterations in the Indian population highlight the utility of broad molecular profiling for successful utilization of targeted therapies. [Table: see text]
Overall survival outcomes in older patients with metastatic breast cancer: A National Cancer Database analysis.
Authors: Rima Patel, Deukwoo Kwon, Amy Tiersten
Journal: Journal of Clinical Oncology (2023)

12049 Background: Over the last few decades, improvements in healthcare have increased life expectancy by nearly 10 years resulting in a rise in America’s older population. As age is one of the most significant risk factors for the development of cancer, there is a projected increase in the incidence of cancer in the elderly population, with the largest absolute and relative increases in breast cancer (BC). Although treatment advances have improved outcomes for patients with metastatic breast cancer (MBC), patients in clinical trials are often younger and there is limited data for the older population. The goals of this study were to use the National Cancer Database (NCDB) to assess overall survival (OS) in older patients over 75 years of age with MBC and evaluate the impact of tumor features and demographic factors. Methods: Women with a diagnosis of BC at age ≥75 years and with metastases at time of initial diagnosis from 2010 to 2019 were identified from the NCDB. Patients were stratified into age subgroups of 75-79, 80-84, and ≥85 years. Chi-square tests were used to compare categorical variables. Kaplan Meier curves were used to determine OS distributions for patients by age, BC subtype and year of diagnosis. Log-rank tests and multivariable cox proportional hazards modeling was performed to assess the difference in OS by BC subtype. Results: Of 17,325 eligible women included in the final analysis, 39.4% were 75-79, 30.1% 80-84, and 30.4% ≥85 years of age. We observed an improvement in OS over time, with 5-year OS rates improving from 13.7% in 2010 to 15.2% in 2015, p = 0.017. Three-year OS rates were higher in patients aged 75-79 (34.2%) compared with patients aged 80-84 (28.7%) and ≥85 years (18.6%), p &lt; 0.001. Outcomes varied by BC subtype with better prognosis in patients with hormone receptor (HR)+, HER2-negative BC (3-year OS 35.1%), followed by HR+, HER2+ (32.8%), HER2+, HR-negative (20.6%) and lastly, HR-negative, HER2-negative BC (9.7%), p &lt; 0.001. Based on multivariable analyses, a higher comorbidity index was associated with worse outcomes (HR 1.654 [1.48-1.849], p &lt; 0.0001). Higher income (≥$63,000) was associated with decreased mortality (HR 0.859 [0.784-0.941], p = 0.0011) compared with lower income ( &lt; $38,000). While the type of cancer facility (academic, community, etc) did not impact mortality, older patients living in metropolitan areas ( &gt; 1 million) had improved outcomes (HR 0.829 [0.689-0.996], p = 0.046), compared to those in rural areas. Conclusions: We observed a modest though significant improvement in survival outcomes over time in older patients with MBC. Prognosis was better in patients with HR+ BC compared with HR-negative, HER2+, and HR-negative, HER2-negative subtypes. However, outcomes in patients ≥85 years remain poor. Given the lack of clinical trial data in older patients with cancer, future studies should specifically focus on improving outcomes in this population.
Patient understanding of immunotherapy and its side effects for women with triple negative breast cancer.
Authors: Madison Canning, Yi Liu, Jeffrey Aldrich, Jeffrey M. Switchenko, Manali A. Bhave
Journal: Journal of Clinical Oncology (2023)

e24046 Background: Immunotherapy (IO) is now an integral part of treatment for most patients with triple negative breast cancer (TNBC). The mechanism of action and associated side effects of IO differ significantly from conventional chemotherapy and patient comprehension of these novel treatments can be difficult to assess. Previous research has demonstrated that patient understanding of anti-cancer treatments is hindered by multiple barriers including education level and healthcare literacy. Standardized educational tools to improve patient comprehension of immunotherapy are integral to improving patient engagement with their treatment plan and providing informed consent. Methods: This is a prospective pilot study investigating the efficacy of standardized educational materials (2 animated videos and 1 pamphlet) to improve patient comprehension of IO. Patients with TNBC were recruited from Emory University between 2021-2022 and were asked three questions related to their understanding of the immune system, immunotherapy, and IO-related side effects before and after viewing the educational tools. Audio-recordings of the patients’ answers were coded as correct or incorrect by two independent reviewers using the video’s definitions as the standard. Clopper-Pearson method and exact McNemar’s test were used to calculate pre- and post-education correct definition rates and paired rates, respectively. Multivariate analyses were conducted investigating the impact of age, highest level of education, and race on patient comprehension. Results: 46 patients with TNBC were enrolled with mean age of 57 years (range 27-84 years). The majority of patients were Black (65%), while the remaining patients were Non-Hispanic White (30%) or unknown (5%). Highest level of education was reported as high school (13%), undergraduate (61%), and graduate school (26%). Comprehension of the terms "immune system" and "immunotherapy" significantly improved after viewing the patient educational material with an increase in correctly defining these terms from 50% to 89.1% (p-value &lt; 0.01) and 41.3% to 82.6% (p-value &lt; 0.01), respectively. Patients' ability to describe two or more side effects of IO also increased from 11% to 87% post-education (p-value &lt; 0.01). Patients with graduate degrees had a 4.24 times greater odds of correctly answering the questions compared to those with undergraduate or high school degrees (p-value 0.057). There were no differences in patient comprehension by race or age. Conclusions: Patient education on novel therapeutics in cancer care including immunotherapy presents a challenge to providers given time constraints in clinic and lack of standardized educational resources. Through easily implemented patient education, we were able to significantly improve patient comprehension of immunotherapy and IO-related side effects in a diverse population of patients with TNBC.
Clinical research policy for oral mucositis associated with cancer treatment (J-SUPPORT).
Authors: Tomoya Yokota, Takao Ueno, Yoshihiko Soga, Hiroto Ishiki, Yasuhito Uezono, Takehiko Mori, Sadamoto Zenda
Journal: Journal of Clinical Oncology (2023)

e24110 Background: Oral mucositis is one of the main areas of research in supportive and palliative care of cancer patients. However, the methodology of prospective clinical trials on oral mucositis has not been established, despite its uniqueness. Here, we propose a novel research policy on oral mucositis, including an implementable set of recommendations for researchers conducting clinical trials. Methods: The first draft was developed by an expert panel of six specialists from the Japanese Supportive, Palliative, and Psychosocial Care Study Group. A provisional draft was developed after review by the following medical societies: the Japanese Association of Supportive Care in Cancer, the Japanese Association of Oral Supportive Care in Cancer, the Japanese Cancer Association, and the receipt of public comments. Results: The research policy on oral mucositis mainly consists of the following components: (i) definition of oral mucositis; (ii) characteristics of oral mucositis; (iii) characteristics of oral mucositis research; (iv) target population for oral mucositis research; (v) endpoints and assessment measures in oral mucositis; (vi) eligibility criteria; (vii) research design; and (viii) minimally recommended intervention in oral mucositis research as a supplement. The final policy (Ver1.0) was completed on August 16, 2021. Conclusions: This policy may serve as a significant reference for planning and conducting clinical trials for the management of oral mucositis.
Durability of responses with biweekly dosing of teclistamab in patients with relapsed/refractory multiple myeloma achieving a clinical response in the majesTEC-1 study.
Authors: Saad Zafar Usmani, Lionel Karlin, Lotfi Benboubker, Hareth Nahi, Jesús San-Miguel, Danielle Trancucci, Keqin Qi, Tara Stephenson, Alfredo Perales-Puchalt, Katherine Chastain, Ajai Chari
Journal: Journal of Clinical Oncology (2023)

8034 Background: Teclistamab is the first B-cell maturation antigen (BCMA) bispecific antibody approved for the treatment of relapsed/refractory multiple myeloma (RRMM) at a dose of 1.5 mg/kg weekly (QW) given subcutaneously. A less frequent dosing schedule offers added convenience and flexibility to patients, physicians, and caregivers. We evaluated the ability of patients to maintain their responses after transitioning from QW to every other week (Q2W) dosing schedules in the pivotal phase 1/2 MajesTEC-1 trial (NCT03145181/NCT04557098). Methods: Eligible patients had RRMM and received ≥3 prior lines of therapy including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody. Prior BCMA-targeted therapy was not allowed in this cohort. Patients received the recommended phase 2 dose (RP2D) of 1.5 mg/kg teclistamab QW, with the option to switch to Q2W dosing if patients achieved a confirmed partial response or better after ≥4 cycles of treatment (phase 1) or a confirmed complete response (CR) or better for ≥6 months (phase 2). Response was assessed per IMWG 2016 criteria. Results: As of Dec 9, 2022, 165 patients in the pivotal cohort had received teclistamab at the RP2D. Of 104 responders, 60 patients switched to Q2W dosing; 50 met the protocol-defined criteria for switching, and 10 switched who did not meet the criteria (4 due to adverse events [AEs]; 6 due to other reasons). Patients who switched had a median age of 64 years, 58% were male, 25% had high-risk cytogenetics, 7% had extramedullary plasmacytomas, and 3% had International Staging System stage III disease at baseline. Patients received a median of 4 prior lines of therapy, and 75% were triple-class refractory. At the time of switch, 49 (82%) patients achieved ≥CR, and 11 (18%) had a very good partial response. Median time to switch from QW to Q2W dosing was 11.1 months (range, 3–20). At median 11.1-month (range, 2–24) follow-up since switching, the median duration of response from the date of switch was 20.5 months (range, 1–23), with 40/60 patients still in response and ongoing treatment. Of the remaining patients, 13/60 have progressed (median time from switch to progression not estimable), 2 discontinued due to AEs, 1 discontinued for other reason, and 4 died. Additional results will be presented. Conclusions: Overall, patients from the MajesTEC-1 study who transitioned from QW to less frequent Q2W dosing of teclistamab had sustained remission, with a median duration of response of 20.5 months from the date of switch. Clinical trial information: NCT03145181 , NCT04557098 .